Effect of Natalizumab on Infarct Volume in Acute Ischemic Stroke "ACTION"

Completed

Phase 2 Results

Trial Description

The primary objective of the study is to determine whether one 300 mg dose of intravenous (IV) natalizumab reduces change in infarct volume from Baseline to Day 5 on magnetic resonance imaging (MRI) in participants with acute ischemic stroke when given at ≤6 hours or at >6 to ≤9 hours from when they were last known normal (LKN).
The secondary objectives of this study in this study population are as follows: to assess the efficacy of natalizumab on change in infarct volume from Baseline to Day 30; to assess efficacy of natalizumab on change in infarct volume from 24 hours to Day 5 and Day 30; to assess the efficacy of natalizumab on clinical measures of stroke outcome; to assess the safety of natalizumab in participants with acute ischemic stroke.

Conditions

Interventions

  • Placebo Drug
    Intervention Desc: Matched placebo
    ARM 1: Kind: Experimental
    Label: Placebo
    Description: a single dose of placebo
  • Natalizumab Drug
    Other Names: BG00002
    Intervention Desc: Administered as described in the treatment arm
    ARM 1: Kind: Experimental
    Label: Natalizumab
    Description: a single dose of natalizumab
  • BG00002 Biological
    Other Names: Natalizumab
    Intervention Desc: 300 mg single intravenous injection
    ARM 1: Kind: Experimental
    Label: BG00002
    Description: a single dose of BG00002
  • BG00002 (Natalizumab) Biological
    Intervention Desc: 300 mg single intravenous injection
    ARM 1: Kind: Experimental
    Label: BG00002
    Description: a single intravenous dose of BG00002

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Investigator)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Change in Infarct Volume from Baseline (Diffusion-Weighted Imaging [DWI]) to Day 5 (Fluid-Attenuated Inversion Recovery [FLAIR]) Day 5 No
Secondary Change in Infarct Volume From Baseline (DWI) to Day 30 (FLAIR) Day 30 No
Secondary Change in Infarct Volume From 24 hours (DWI) to Day 5 and Day 30 (FLAIR) Up to Day 30 No
Secondary Change in National Institute of Health Stroke Scale (NIHSS) Score from Baseline to 24 hours, Day 5, Day 30, and Day 90 Up to Day 90 No
Secondary Modified Rankin Scale (mRS) distribution at Day 5, Day 30, and Day 90 Up to Day 90 No
Secondary Barthel Index at Day 5, Day 30, and Day 90 Up to Day 90 No
Secondary Number of subjects who experience Adverse Events (AEs) and Serious Adverse Events (SAEs) Up to Day 90 Yes
Secondary Number of participants who experience Adverse Events (AEs) and Serious Adverse Events (SAEs) Up to Day 90 Yes
Secondary Change in Infarct Volume From Baseline (DWI) to 24 Hours (FLAIR) Baseline, 24 hrs No
Secondary Change in Infarct Volume From 24 Hours (FLAIR) to Day 5 (FLAIR) 24 hours, Day 5 No
Secondary Change in Infarct Volume From 24 Hours (FLAIR) to Day 30 (FLAIR) 24 hours, Day 30 No
Secondary Change in Infarct Volume From Day 5 (FLAIR) to Day 30 (FLAIR) Day 5, Day 30 No

Sponsors